Topical 2% Amitriptyline and 1% Ketamine in Neuropathic Pain Syndromes: A Randomized, Double-blind, Placebo-controlled Trial

Background: A double-blind, randomized, placebo-controlled 3-week study evaluated the efficacy of topical 2% amitriptyline, 1% ketamine, and a combination of both in treating patients with neuropathic pain.

Methods: Ninety-two patients with diabetic neuropathy, postherpetic neuralgia, or postsurgical/posttraumatic neuropathic pain with allodynia, hyperalgesia, or pinprick hypesthesia were randomly assigned to receive one of four creams (placebo, 2% amitriptyline, 1% ketamine, or 2% amitriptyline-1% ketamine combined). The primary outcome measure was change in average daily pain intensity (baseline week vs. final week) using an 11-point numerical pain rating scale. Secondary outcomes included the McGill Pain Questionnaire, measures of allodynia and hyperalgesia, and patient satisfaction.

Results: A reduction in pain scores of 1.1-1.5 units was observed in all groups, and there was no difference between groups. Blood concentrations revealed no significant systemic absorption. Minimal side effects were encountered.     

Effect of Postoperative Epidural Analgesia on Rehabilitation and Pain after Hip Fracture Surgery: A Randomized, Double-blind, Placebo-controlled Trial

Background: Hip fracture surgery usually carries a high demand for rehabilitation and a significant risk of perioperative morbidity and mortality. Postoperative epidural analgesia may reduce morbidity and has been shown to facilitate rehabilitation in elective orthopedic procedures. No studies exist on the effect of postoperative epidural analgesia on pain and rehabilitation after hip fracture surgery.

Methods: Sixty elderly patients were included in a randomized, double-blind study comparing 4 days of continuous postoperative epidural infusion of 4 ml/h bupivacaine, 0.125%, and 50 [mu]g/ml morphine versus placebo. Both patient groups received balanced analgesia and intravenous nurse-controlled analgesia with morphine. All patients followed a well-defined multimodal rehabilitation program. Pain, ability to participate in four basic physical functions, and any factors restricting participation were assessed on the first 4 postoperative days during physiotherapy.

Results: Epidural analgesia provided superior dynamic analgesia during all basic physical functions, and patients were significantly less restricted by pain, which was the dominating restricting factor in the placebo group. Motor blockade was not a restricting factor during epidural analgesia. Despite improved pain relief, scores for recovery of physical independence were not different between groups.     

Preemptive Analgesia: Intraperitoneal Local Anesthetic in Laparoscopic Cholecystectomy: A Randomized, Double-blind, Placebo-controlled Study

Background: A controversy exists over the effectiveness and clinical value of preemptive analgesia. Additional studies are needed to define the optimum intensity, duration, and timing of analgesia relative to incision and surgery.

Methods: One hundred twenty patients undergoing laparoscopic cholecystectomy under general anesthesia plus topical peritoneal local anesthetic or saline were studied. Local anesthetic (0.5% bupivacaine with epinephrine) or placebo solutions were given as follows: immediately after the creation of a pneumoperitoneum (blocking before surgery), and at the end of the operation (blocking after surgery). Patients were randomly assigned to one of four groups of 30 patients each. Group A (placebo) received 20 ml 0.9% saline both before and after surgery, group B received 20 ml 0.9% saline before surgery and 20 ml local anesthetic after surgery, group C received 20 ml local anesthetic both before and after surgery, group P received 20 ml local anesthetic before and 20 ml 0.9% saline after surgery. Pain was assessed using a visual analog scale and a verbal rating scale at 0, 4, 8, 12, and 24 h after surgery. Metabolic endocrine responses (blood glucose and cortisol concentrations) and analgesic requirements also were investigated.

Results: Pain intensity (visual analog and verbal rating scales) and analgesic requirements were significantly less in the group receiving bupivacaine after surgery compared to placebo. However, in the groups receiving bupivacaine before surgery, both pain intensity and analgesic consumption were less than in the group receiving bupivacaine only after surgery. Blood glucose and cortisol concentrations 3 h after surgery were significantly less in groups receiving bupivacaine before surgery.     

Tranexamic Acid Administration after Cardiac Surgery: A Prospective, Randomized, Double-blind, Placebo-controlled Study

Background: Many different doses and administration schemes have been proposed for the use of the antifibrinolytic drug tranexamic acid during cardiac surgery. This study evaluated the effects of the treatment using tranexamic acid during the intraoperative period only and compared the results with the effects of the treatment continued into the postoperative period.

Methods: Patients undergoing elective cardiac surgery with use of cardiopulmonary bypass (N = 510) were treated intraoperatively with tranexamic acid and then were randomized in a double-blind fashion to one of three postoperative treatment groups: group A: 169 patients, infusion of saline for 12 h; group B: 171 patients, infusion of tranexamic acid, 1 mg [middle dot] kg-1 [middle dot] h-1 for 12 h; group C: 170 patients, infusion of tranexamic acid, 2 mg [middle dot] kg-1 [middle dot] h-1 for 12 h. Bleeding was considered to be a primary outcome variable. Hematologic data, allogeneic transfusions, thrombotic complications, intubation time, and intensive care unit and hospital stay duration also were evaluated.

Results: No differences were found among groups regarding postoperative bleeding and outcomes; however, the group treated with 1 mg[middle dot]kg-1[middle dot]h-1 tranexamic acid required more units of packed red blood cells because of a significantly lower basal value of hematocrit, as shown by multivariate analysis.     

A Double-blind, Placebo-controlled Trial of Ciprofloxacin Prophylaxis in Patients with Acute Necrotizing Pancreatitis

Background  The use of prophylactic antibiotics in acute severe necrotizing pancreatitis is controversial. Methods  Prospective, randomized, placebo-controlled, double-blind study was carried out at Bellvitge Hospital, in Barcelona, Spain. Among 229 diagnosed with severe acute pancreatitis, 80 had evidence of necrotizing pancreatitis (34/80 patients were excluded of the protocol). Forty-six patients without previous antibiotic treatment with pancreatic necrosis in a contrast-enhanced CT scan were randomly assigned to receive either intravenous ciprofloxacin or placebo. Five patients were secondarily excluded, and the remaining 41 patients were finally included in the study (22 patients received intravenous ciprofloxacin and 19 patients placebo). Results  Comparing the 22 with intravenous ciprofloxacin and 19 with placebo, infected pancreatic necrosis was detected in 36% and 42% respectively (p = 0.7). The mortality rate was 18% and 11%, respectively (p = 0.6). No significant differences between both treatment groups were observed with respect to variables such as: non-pancreatic infections, surgical treatment, timing and the re-operation rate, organ failure, length of hospital and ICU stays. Conclusion  The prophylactic use of ciprofloxacin in patients with severe necrotizing pancreatitis did not significantly reduce the risk of developing pancreatic infection or decrease the mortality rate. The small number of patients included in this study should be considered. This study was promoted by the “Bellvitge Hospital” and has not received any grant or payment from the pharmaceutical industry.     

Influence of Probiotics Administration Before Liver Resection in Patients with Liver Disease: A Randomized Controlled Trial

World Journal of Surgery - By inhibiting the growth of pathogenic bacteria and modulating the local intestinal immune system, probiotics may reduce bacterial translocation and systemic...     

Efficacy and Safety of Tamsulosin in Medical Expulsive Therapy for Distal Ureteral Stones with Renal Colic: A Multicenter,Randomized, Double-blind,Placebo-controlled Trial

Background

Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones.

A Randomized,Double-blind,Placebo-controlled Clinical Study Investigating the Efficacy and Tolerability of a Peptide Serum Targeting Expression Lines

Clinical Trial ID: NCT0454597BACKGROUND: Mimetic wrinkles, commonly referred to as expression lines, form perpendicular to anatomical regions subjected to repeated facial muscle contraction. Neuromodulating peptides have biological activity and can offer a solution to those concerned with expression lines and facial aging. OBJECTIVE: The objective of this randomized, double-blind, placebo-controlled study was to assess the efficacy and tolerability of a line-targeting peptide serum (LTPS) as a stand-alone treatment in improving expression lines and skin health. METHODS: This was an institutional review board-approved study involving healthy subjects. Fifty-five female subjects, 35 to 60 years old, Fitzpatrick Skin Type I to VI, with mild to moderate global face fine lines and wrinkles were recruited. Subjects were randomized to apply LTPS or a placebo serum to their face twice daily for twelve weeks. Short-term efficacy was assessed after fifteen minutes of serum application at baseline. Long-term efficacy and tolerability, self-assessment questionnaire, and VISIA^® clinical photography were performed at baseline, Weeks 4, 8, and 12. 3D PRIMOS CR imaging and wrinkle analysis were obtained at baseline and Weeks 8 and 12. RESULTS: The LTPS significantly improved expression lines at fifteen minutes (short term), Weeks 4, 8, and 12 (long term) when compared to the placebo serum as evaluated by a board-certified dermatologist. The LTPS significantly outperformed the placebo serum in improving skin parameters at all time points. VISIA and PRIMOS CR wrinkle analysis substantiated the LTPS’s efficacy. LTPS was well-perceived and well tolerated by the subjects. CONCLUSION: This IRB-approved clinical study demonstrated that LTPS was effective in improving expression lines, wrinkles, and skin health after twelve weeks of application.     

A Randomized,Double-blind,Placebo-controlled,Multi-center,Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair

Objective: The purpose of this six-month, randomized, double-blind, multi-center, placebo-controlled study was to determine if the administration of a new oral supplement will promote terminal hair growth. Design: A randomized, double-blind study. Setting: Two private practices (dermatology and facial plastics). Participants: Women 21 to 75 years of age with self-perceived thinning hair. Measurements: The primary efficacy endpoint was the change in terminal and vellus hairs in a 4cm² target area of the scalp after 90 and 180 days of treatment. Secondary endpoints were change in hair diameter and responses to Quality of Life and Self-Assessment questionnaires. Results: Subjects treated with the new oral supplement achieved a significant increase in the number of baseline terminal hairs at 90 and 180 days (for each, p<0.0001, respectively) and were significantly greater then placebo (p<0.0001). Treatment with the new oral supplement was also associated with a significant increase in baseline terminal hair diameter after 90 (p=0.006) and 180 days of treatment (p=0.001) which was significantly greater than placebo at the end of the study (p=0.003). Improvements in hair growth and hair diameter were associated with significant improvement in most responses to Self-Assessment and Quality of Life Questionnaire responses. There were no adverse events. Conclusion: The daily administration of a new oral supplement was associated with significant increases in the number of terminal and vellus hairs and hair diameter. Most study participants believed the use of the oral supplement resulted in significant improvement in skin and hair quality and quality of life.As physicians, we may look at a patient and think she has no problem with hair thinning or hair loss, but she may feel very strongly that her hair is thinning. Hair loss in women can appear as early as in their 20s, and with environmental stress, internal stress, multiple medications, and dietary insufficiencies, can often progress. While androgenetic alopecia is a common cause of male pattern hair loss in men and a less common cause of female pattern hair loss in women,1 this study is not one of androgenetic alopecia. Among women, hair loss is more likely to be due to medications,2 nutritional deficiency,3 and physiological or emotional stresses, such as illness or childbirth.2,4-7 Hair loss and decreased hair fiber thickness are reasons for many older women becoming dissatisfied with their hair8 and for many, hair loss may be associated with symptoms of depression9 and diminished quality of life.10 The authors wanted to determine if patients with self-perceived thinning hair due to daily life stressors (not a specific trigger inducing hair loss as seen with telogen effluvium), nutritional insufficiency (fast food, poor diet), and aging (again not androgenetic alopecia with retention of frontal hair line or central part of scalp) would truly benefit from a new all natural, oral supplement.The product containing proteins and glycosaminoglycans of marine origin and other natural compounds has been developed for the treatment of androgenetic alopecia (Vivisca® Hair Nourishment System, Lifes2good, Inc., Chicago, Illinois). This product does not contain hormones, drugs, or industry by-products but it provides essential nutrients to nourish hair naturally. Two 8- and 12-month open-label studies11,12 have demonstrated the efficacy of this product for the treatment of alopecia in men. The results of the authors’ recent pilot study, published in The Journal of Clinical and Aesthetic Dermatology in November 2012, showed that the oral supplement was also effective in women with thinning hair due to poor diet, stress, hormonal influences, or abnormal menstrual cycles.13 Subjects enrolled in that study achieved a significant increase in the number of terminal hairs among Viviscal-treated subjects after 90 and 180 days of daily treatment. In addition, significantly more Viviscal-treated subjects perceived improvements in overall hair volume, scalp coverage, thickness of hair body, hair shine, skin moisture retention, and skin smoothness after 180 days.Further studies are also being conducted to establish the molecular mechanism by which the new oral supplement promotes hair growth. While the exact mechanism of this product is unknown, some of the preliminary data from early in vitro studies have shown that the polysaccharide complexes in it have greater bioavailability when compared with similar products (unpublished results). In addition, this new product has been shown to enhance the proliferation of dermal papillae (DP) cells. DP cells have been shown to play an important role in orchestrating the hair growth cycle.14,15 Initial studies have shown that this new supplement increases alkaline phosphatase (AP) levels in DP cells (unpublished results). AP is a key marker of the anagen phase; therefore, an increase in its expression suggests an increase in the quantity of DP cells that are actively growing during the anagen phase.15-17 Thus, in vitro examination of the molecular mechanism of Viviscal is consistent with the results of the existing Viviscal clinical studies, where daily intake promotes existing hair growth.A new professional strength supplement has been specifically designed to promote hair growth in women suffering from temporary thinning hair (New Vivisca® Professional Strength Oral Tablets, Lifes2good, Inc., Chicago, Illinois). The purpose of this multi-center randomized, double-blind, placebo-controlled study was to test the hypothesis that the administration of a new oral supplement for 180 days will promote the growth of terminal hairs and increase hair diameter in a larger group of adult women with self-perceived thinning hair, adding the factor of hair diameter changes due to the product in our evaluation.Open in a separate windowFigure 1Changes in hair growth, Patient 1. Top Row. Macrophotographs of the selected target area at baseline (left), 90 days (center), and 180 days (right). Bottom row. Digital images of the selected target area at baseline (left), 90 days (center), and 180 days (right).Open in a separate windowFigure 2Changes in hair growth, Patient 2. Top Row. Macrophotographs of the selected target area at baseline (left), 90 days (center), and 180 days (right). Bottom row. Digital images of the selected target area at baseline (left), 90 days (center), and 180 days (right).     

Recombinant Factor VIIa in Pediatric Cardiac Surgery

ObjectivesRecombinant activated factor VIIa (rVIIa) is used off-label for refractory bleeding after cardiac surgery. This study reviewed the indications, usage rates, and complications of rVIIa.DesignA retrospective case-control observational study.SettingA single quaternary pediatric hospital.ParticipantsAll children undergoing cardiac surgery with cardiopulmonary bypass over a three-year period.InterventionsAdministration of rVIIa as rescue therapy for refractory bleeding after weaning from cardiopulmonary bypass.Measurements and Main ResultsOnethousand, five hundred fifteen cardiopulmonary bypass procedures were reviewed. Patients receiving rVIIa were each matched to two control patients by age, procedure type, and bypass time. Data collected included weight, crossclamp time, anticoagulant and antifibrinolytic dose, return to the operating room for bleeding, thrombotic events, and extracorporeal membrane oxygenation (ECMO) circuit interventions.Forty-two patients received rVIIa (2.8%). Major systemic thrombotic complications were observed in 19% (controls 12.5%) of patients; 80% of recombinant factor VIIa patients requiring postoperative ECMO had interventions for circuit thrombosis (controls 31.25%); 4.76% of rVIIa recipients required reexploration for intractable bleeding (controls 1.39%).ConclusionsThis study added to understanding regarding the use of recombinant factor VIIa in pediatric cardiac surgery and reported increased thrombotic complications, especially for children who progress to ECMO. Prospective studies to better understand the pathophysiology of coagulopathy and hemorrhage in pediatric cardiac surgery and the role of hemostatic agents, such as rVIIa, are required.     

Correction to: Influence of Probiotics Administration Before Liver Resection in Patients with Liver Disease: A Randomized Controlled Trial

World Journal of Surgery -     

Morphine versus Mexiletine for Treatment of Postamputation Pain: A Randomized, Placebo-controlled, Crossover Trial

Background: Stump and phantom pains are debilitating sequelae of amputations that are often resistant to treatment. The efficacy of pharmacologic therapies, including opioids and sodium channel blockers, for postamputation pain is uncertain.

Methods: The authors conducted a double-blind, randomized, placebo-controlled, crossover study in adult patients with postamputation pain of 6 months or longer and greater than 3 on a 0-10 numeric pain rating scale. Each of the three treatment periods (morphine, mexiletine, or placebo) included a 1-week drug-free interval followed by 4-week titration, 2-week maintenance, and 2-week drug-taper phases. The primary outcome measure was change in average pain intensity from the drug-free baseline to the last week of maintenance.

Results: Sixty amputees were enrolled; data were analyzed from 56 subjects for one drug period, 45 subjects for two drug periods, and 35 subjects who completed all three drug periods. The mean morphine and mexiletine dosages were 112 and 933 mg, respectively. Morphine treatment provided lower pain scores compared with placebo and mexiletine (P = 0.0003). The mean percent pain relief during treatment with placebo, mexiletine, and morphine was 19, 30, and 53%, respectively (P < 0.0001, morphine vs. placebo and mexiletine). The numbers needed to treat to obtain 50% and 33% decreases in pain intensity with morphine were 5.6 and 4.5, respectively. Treatment with morphine was associated with a higher rate of side effects.     

Ischemic Pre-conditioning in Deceased Donor Liver Transplantation: A Prospective Randomized Clinical Trial

To assess the immediate and long-term effects of ischemic preconditioning (IPC) in deceased donor. liver transplantation (LT), we designed a prospective, randomized controlled trial involving 60 donors: control group (CTL, n = 30) or study group (IPC, n = 30). IPC was induced by 10-min hiliar clamping immediately before recovery of organs. Clinical data and blood and liver samples were obtained in the donor and in the recipient for measurements. IPC significantly improved biochemical markers of liver cell function such as uric acid, hyaluronic acid and Hypoxia-Induced Factor-1 alpha (HIF-1 alpha) levels. Moreover, the degree of apoptosis was significantly lower in the IPC group. On clinical basis, IPC significantly improved the serum aspartate aminotransferase (AST) levels and reduced the need for reoperation in the postoperative period. Moreover, the incidence of primary nonfunction (PNF) was lower in the IPC group, but did not achieve statistical significance. We conclude that 10-min IPC protects against I/R injury in deceased donor LT.     

A Randomized, Double-blinded Placebo-controlled Clinical Trial of the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

Background

The effectiveness of antibiotic prophylaxis for prevention of surgical site infection (SSI) following specific types of breast cancer surgery remains uncertain. This study assessed the effectiveness of prophylaxis in modified radical mastectomy (MRM).

Methods

Women undergoing MRM for breast cancer were recruited. Women were excluded who had diabetes mellitus, severe malnutrition or known allergy to cephalosporins; were receiving corticosteroid therapy or were treated with antibiotics within one week prior to surgery; were scheduled for simultaneous breast reconstruction or bilateral oophorectomy; had existing local infection. Participants were randomized to receive either intravenous cefazolin 1 g or placebo within 30 min prior to skin incision. Standard skin preparation and operative technique for MRM were carried out. Wounds were assessed for SSI and other complications weekly for 30 days.

Results

A total of 254 women were recruited. Age, clinical stage, prior chemotherapy, and operative time were similar for antibiotic and placebo groups. The overall incidence of SSI was 14.2 %. There were no significant differences in the infection rate over the 30-day follow-up period between the placebo and antibiotic groups (15 % vs 13.4 %; p = 0.719) or at each week. The majority of SSI were either cellulitis or superficial infection for both groups. There were no significant differences between groups in treatments required for SSI, incidence of hematoma or seroma.

Conclusions

The findings of this study, alone and when meta-analyzed with data from studies in similar surgical populations, do not support the use of antibiotic prophylaxis in MRM.     

Monopolar Floating Ball Versus Bipolar Forceps for Hepatic Resection: A Prospective Randomized Clinical Trial

Background  Hepatic transection by Pean-clasia is the mainstream technique that can be used with different coagulators. Monopolar floating ball (MFB) is proposed for liver transection. Whether its value for liver transection is unclear, its efficiency as a coagulator only seems high. We compared in a prospective randomized study the standard Pean-clasia with bipolar forceps (BF) versus Pean-clasia with MFB in patients undergoing hepatic resection. Methods  Seventy-six patients scheduled for hepatectomy were randomized in two groups, according to the coagulator device: group A (MFB, n = 38) and group B (BF, n = 38). The two groups were homogeneous in terms of tumor presentation and background liver features. Blood loss, blood transfusions, transection time, number of ligatures, drain discharge, drain bilirubin levels at third, fifth, and seventh postoperative day, and postoperative morbidity and mortality were prospectively evaluated. Results  No significant differences between groups A and B were seen in terms of blood transfusions (11.5% versus 16.5%; p = 0.450), blood loss/cm² (mean 7.2 versus 7.6 ml; p = 0.450), transection time/cm² (mean 2.1 versus 2.3; p = 0.070), number of ligatures/cm² (mean 0.7 versus 0.7; p = 1), drain discharge (mean 55 versus 66.7 ml; p = 0.451), and drain bilirubin levels (mean 1.9 versus 2.1 mg/dl; p = 0.664). No mortality or major morbidity was recorded in both groups. Conclusions  This study showed that association of Pean-clasia with MFB was safe and minimized the blood loss during hepatic resection. However, MFB did not offer significant benefits over BF, while its cost is not negligible.     

A Randomized Double-blind Placebo-controlled Phase 2 Dose-ranging Study of OnabotulinumtoxinA in Men with Benign Prostatic Hyperplasia

Background

Botulinum toxin treatment has been investigated as a minimally invasive alternative to oral medications in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH).

Objective

To explore the efficacy of onabotulinumtoxinA 100 U, 200 U, and 300 U versus placebo in men with LUTS/BPH in a phase 2 dose-ranging study.

Design, setting, and participants

A multicenter double-blind randomized, placebo-controlled 72-wk study enrolled men ≥50 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥12, total prostate volume (TPV) 30–100 ml, and maximum flow rate (Q_max) 5–15 ml/s.

Intervention

Single transperineal (n = 63) or transrectal (n = 311) administration of placebo (n = 94) or onabotulinumtoxinA 100 U (n = 95), 200 U (n = 94), or 300 U (n = 97) into the prostate transition zone.

Outcome measurements and statistical analysis

The primary efficacy end point was a change from baseline in IPSS at week 12. Secondary end points were Q_max, TPV, and transition zone volume (TZV). Analysis of covariance and the Cochran-Mantel-Haenszel method assessed the efficacy and proportion of IPSS responders. Adverse events (AEs) were assessed.

Results and limitations

Significant improvements from baseline in IPSS, Q_max, TPV, and TZV were observed for all groups, including placebo, at week 12 (p < 0.001), with no significant differences between onabotulinumtoxinA and placebo. However, in an exploratory post hoc analysis, a significant reduction in IPSS versus placebo was observed with onabotulinumtoxinA 200 U in prior α-blocker users (n = 180) at week 12. AEs were comparable across all groups.

Conclusions

Reductions in LUTS/BPH symptoms were seen in all groups, including placebo, with no significant between-group differences owing to a large placebo effect from the injectable therapy. The findings from the post hoc analysis in men previously treated with α-blockers will be further explored in an appropriately designed study.

Trial registration

http://www.Clinical Trials.gov; NCT00284518.     

Fascia Iliaca Compartment Blockade for Acute Pain Control in Hip Fracture Patients: A Randomized, Placebo-controlled Trial

Background: Hip fracture patients are in severe pain upon arrival at the emergency department. Pain treatment is traditionally based on systemic opioids. No study has examined the effect of fascia iliaca compartment blockade (FICB) in acute hip fracture pain management within a double-blind, randomized setup.

Methods: Forty-eight patients with suspected hip fracture were included immediately after arrival in the emergency department, before x-ray confirmation of their fracture. Included patients were randomly assigned to two groups of 24. In the FICB group, the patients received an FICB with 1.0% mepivacaine and a placebo intramuscular injection of isotonic saline. In the morphine group, the patients received a placebo FICB with 0.9% saline and an intramuscular injection of 0.1 mg/kg morphine. Patients received intravenous rescue morphine when necessary.

Results: Maximum pain relief was superior in the FICB group both at rest (P < 0.01) and on movement (P = 0.02). The median total morphine consumption was 0 mg (interquartile range, 0-0 mg) in the FICB group and 6 mg (interquartile range, 5-7 mg) in the morphine group (P < 0.01). More patients (P = 0.05) were sedated in the morphine group at 180 min after block placement as compared with the FICB group.